Jaeger Medical GmbH

FDA Device Registration & Listing · HOECHBERG Bavaria, DE · Registration 9615102

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615102
FEI Number
1000271197
Entity Name
Jaeger Medical GmbH
City/State/Country
HOECHBERG Bavaria, DE
Establishment Address
LEIBNIZSTRASSE 7, HOECHBERG Bavaria 97204, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Jaeger Medical GmbH (Owner Number: 10092652)
Owner / Operator Contact Address
Leibnizstrasse 7, Hoechberg, DE-BY 97204, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K113096
PMA Number
N/A

All Registered Proprietary Names

MicroLab SpiroUSB Smokecheck MicroCO Sentry Connect Interface (MDDS) MasterScreen Diffusion MasterScreen Body SpiroSoft Vyntus ONE VIP Pulmonary Function System Disposable Mouthpiece, Flex V-892894 Disposable Mouthpiece, plastic 892103 Disposable Mouthpiece, plastic V-892896 Disposable Mouthpiece, Flex V-892893 Disposable Mouthpiece, Flex V-892897 MasterScreen Pneumo SentrySuite Product Line 2.7 MicroLoop MicroLab Pulmolife Oxycon Mobile ApnoeScreen Pro MicroGP / MicroDL NeuroScreen Oxycon Pro MicroRPM MicroGard I Microgard Microbial Filter N2O Test MS CPX partially mobile SentrySuite Product Line 2.3 MicroPeak CO Test Gas Cylinder 706960 Pressure Regulator Static and Dynamic Compliance for Vmax APS Pro Vyntus BODY Vyntus CPX / Vyntus ECG MS Paed - Baby Body Ergotest 40 & 45 Vyntus SPIRO MasterScreen Pneumo Unerversal Ergotest Micro Spirometer MasterScreen PFT Body MasterScreen CPX & Oxycon CPX Vyntus / SentrySuite Product Line Vyntus ECG O2 Test CO2 Test Micro I Diagnostic Spirometer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04
CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase Anesthesiology Class 2 868.1430 2025-02-04
OUG Medical Device Data System General Hospital Class 1 880.6310 2025-02-04
JEH Plethysmograph, Volume Anesthesiology Class 2 868.1760 2025-02-04
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-02-03
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-04
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2025-02-04
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-04
JEH Plethysmograph, Volume Anesthesiology Class 2 868.1760 2025-02-03
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-03
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-03
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-03
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04
DQA Oximeter Cardiovascular Class 2 870.2700 2025-02-04
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2025-02-04
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-02-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-02-04
MLC Monitor, St Segment Cardiovascular Class 2 870.2340 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-02-04
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2025-02-04
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2025-02-04
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-03
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-03
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-03
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2025-02-04
CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase Anesthesiology Class 2 868.1430 2025-02-04
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2025-02-04
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-03
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-03
JEH Plethysmograph, Volume Anesthesiology Class 2 868.1760 2025-02-03
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-03
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-02-03
MLC Monitor, St Segment Cardiovascular Class 2 870.2340 2025-02-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-02-03
CCM Plethysmograph, Pressure Anesthesiology Class 2 868.1750 2025-02-04
ISP Valve, Prosthesis Physical Medicine Class 1 890.3420 2025-02-04
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-02-03
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2025-02-04
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04
JEH Plethysmograph, Volume Anesthesiology Class 2 868.1760 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-02-04
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2025-02-04
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-02-04
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-02-04

Official Correspondent

Jared Cardon

US Agent Details

Cally Kothmann Business: Jaeger Medical America Email: GMB-RDX-Regulatory@jaegerrdx.com Phone: (714) 6858094

Related Public Records

Same Entity

Jaeger Medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3033959233 Jaeger Medical America Inc. Moreno Valley, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K923989 Sensor Medics Corp. SENSORMEDICS MODEL 6200 AUTOBOX DL 1993-08-09
K862544 Suzuken Co., Ltd. KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH 1986-08-06
K802368 Marquette Electronics, Inc. OPTION 301 PACEMAKER EVAL. MODULE MAC-1 1981-03-04
K131503 Edan Instruments, Inc. SE-601 SERIES ELECTROCARDIOGRAPH 2014-02-25
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2022 Welch Allyn Inc Mortara 2
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012 Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China 2
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615102. Last updated year: 2026. Please use registration number 9615102 when referencing this establishment in official correspondence.
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